Trial Outcomes & Findings for Evaluation of a Novel Electronic Urine Output Monitor (eUOM) (NCT NCT02195713)

Results Overview

Urine output as recorded by the SOC when connected to a standard Foley catheter and standard urinary drainage tube will be compared to urine output recorded by Accuryn and the SOC when connected to a standard Foley catheter and the Accuryn Drainage Tube.

Recruitment status

COMPLETED

Target enrollment

20 participants

Primary outcome timeframe

2 - 5 days

Results posted on

2016-02-22

Participant Flow

Participant milestones

Participant milestones
Measure	Test- Accuryn Urine Output Monitor Accuryn Anti-airlock Drainage System was attached to the Foley catheter and urine output / drainage line pressure was monitored. Accuryn: Accuryn is a novel electronic urine output monitor	Control- Critcore Urine Output Monitor A commercially available urine output monitor (Criticore, Bard Medical) was attached to the Foley catheter and urine output / drainage line pressure was monitored.
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of a Novel Electronic Urine Output Monitor (eUOM)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test- Accuryn Urine Output Monitor n=9 Participants Accuryn Anti-airlock Drainage System was attached to the Foley catheter and urine output / drainage line pressure was monitored. Accuryn: Accuryn is a novel electronic urine output monitor	Control- Critcore Urine Output Monitor n=9 Participants A commercially available urine output monitor (Criticore, Bard Medical) was attached to the Foley catheter and urine output / drainage line pressure was monitored.	Total n=18 Participants Total of all reporting groups
Age, Continuous	44 years STANDARD_DEVIATION 22 • n=5 Participants	52 years STANDARD_DEVIATION 17.9 • n=7 Participants	49 years STANDARD_DEVIATION 20.2 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	9 participants n=7 Participants	18 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 - 5 days

Urine output as recorded by the SOC when connected to a standard Foley catheter and standard urinary drainage tube will be compared to urine output recorded by Accuryn and the SOC when connected to a standard Foley catheter and the Accuryn Drainage Tube.

Outcome measures

Outcome measures
Measure	Test- Accuryn Urine Output Monitor n=10 Participants Accuryn Anti-airlock Drainage System was attached to the Foley catheter and urine output / drainage line pressure was monitored. Accuryn: Accuryn is a novel electronic urine output monitor	Control- Critcore Urine Output Monitor n=10 Participants A commercially available urine output monitor (Criticore, Bard Medical) was attached to the Foley catheter and urine output / drainage line pressure was monitored.
Urine Output of SOC Device Versus Accuryn	0 Patients with airlocks Interval 0.0 to 0.0	5 Patients with airlocks Interval 5.0 to 5.0

Adverse Events

Test- Accuryn Urine Output Monitor

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control- Critcore Urine Output Monitor

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Devyani Nanduri

Theranova, LLC

Phone: 415-926-8616

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place